Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 00304040004036
• Version / Model: 1068473
• Catalog Number: 1068473
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a31bd67a-65a4-487d-bfbd-22e77760d26e

Device Description

Ortho Primer Refill

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYH	ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN	Dental	872.3750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31750	Orthodontic bracket adhesive	A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00304040004036	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Bottle
Total Volume	9	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of sun
• Type: Storage Environment Temperature
• Temperature Range: 50 – 75 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 10 – 24 Degrees Celsius